Food Products

ABSTRACT

Food products for the dietary management of a diet-responsive disease or condition, a method of dietary management of a diet-responsive disease or condition, and a system for providing such food products are disclosed. In one embodiment, the system involves (a) providing the name of at least one medical professional or medical professional&#39;s office or practice for consultation by participants and, if applicable, for writing orders for food products for participants; (b) providing controlled access to a supply of food products; and (c) providing the food products to the participants. The food products can be supplied in any suitable manner. Suitable manners of providing a supply of food products include, but are not limited to providing the food products at retail outlets, such as stores that have pharmacies, and drug stores, or through a website.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Nos.61/163,914; 61/163,922; and 61/163,925, all of which were filed on Mar.27, 2009, which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention is directed to food products for the dietarymanagement of a diet-responsive disease or condition, methods of dietarymanagement of a diet-responsive disease or condition, and systems forproviding such food products.

BACKGROUND OF THE INVENTION

Numerous diet products and programs have been developed for variouspurposes. ALLI™ is the reduced-strength version of orlistat (brandedname XENICAL®), a prescription drug to treat obesity. It is approved forover-the-counter sale to overweight adults 18 years and older. ALLI™ ismeant to be used in conjunction with a low-calorie, low-fat diet andregular exercise. Other diet products and programs include: GLUCERNA®nutritional products for people with diabetes (sold by AbbottLaboratories); Campbell Soup Company's INTELLIGENT QUISINE® program (seeU.S. Pat. Nos. 5,639,471; 5,977,059; 5,994,295; 6,039,978; 6,039,989;6,102,706; and 6,189,330 B1); NUTRISYSTEM® weight loss system;Physicians WEIGHT LOSS Centers® programs; STOUFFER'S® LEAN CUISINE®foods; and WEIGHT WATCHERS® weight loss program (see U.S. Pat. Nos.4,652,241; 6,040,531; and 6,878,885 B2).

Several other diet products and programs are described in the patentliterature. Nutritional compositions used in the treatment or preventionof metabolic syndrome, diabetes or obesity are described in U.S. PatentApplication Publication US 2004/0087514 A1, published in the name ofHughes, et al. A method of using gamma cyclodextrin to control bloodglucose and insulin secretion is described in U.S. Patent ApplicationPublication US 2005/0215523 A1, published in the name of Lai, et al.

Some current dietary or nutritional programs involve the use of medicalfoods. “Medical foods” are defined by the U.S. Food and DrugAdministration as a “food which is formulated to be consumed oradministered enterally under the supervision of a physician and which isintended for the specific dietary management of a disease or conditionfor which distinctive nutritional requirements, based on recognizedscientific principles, are established by medical evaluation.” Suppliersof medical foods include: Abbott Nutrition (www.abbottnutrition.com);Applied Nutrition Corp. (www.medicalfood.com); Metagenics(www.metagenics.com); Nationwide Medical Foods (www.medicalfoods.com);Nutricia North America (www.nutriciana.com); and Primus Pharmaceuticals(www.limbrel.com). These medical foods are often provided in the form ofmeal replacement products, such as liquids, cereals, snack bars, mealbars, pills, and shakes, rather than in the form of actual food dishesas part of a meal.

Many diet programs rely on reducing serving portion size to reduce theintake of calories. This can leave the dieting individual feelinghungry. Other products and programs provide reduced calorie foods;however, often such foods are poor tasting. The search for improved dietfoods and foods for dietary management of a diet-responsive disease orcondition, and methods of dietary management of a diet-responsivedisease or condition has, therefore, continued. In particular, it isdesirable to provide diet foods and food products for dietary managementof a diet-responsive disease or condition that have a good taste whichare provided in substantial sized portions, but which have significantcalorie and fat reduction compared to non-diet (i.e., full calorie)equivalent foods.

SUMMARY OF THE INVENTION

The present invention is directed to food products for the dietarymanagement of a diet-responsive disease or condition, methods of dietarymanagement of a diet-responsive disease or condition, and systems forproviding such food products. There are numerous non-limitingembodiments of the present invention.

In one non-limiting embodiment, food products for dietary management ofa diet-responsive disease or condition are provided which contain a fatreplacement ingredient. The food products may be in any suitable formincluding, but not limited to, in the form of, or as a component of afrozen or shelf stable: complete meal, main course of a meal, appetizer,entree, side dish for a meal, sauce, dressing, dessert, snack, cookedfood, hot food, microwavable food, cooking oils, and spreads. The foodproducts may be prepared using recipes which have been modified toreplace at least some of the digestible fat with a fat replacementingredient and then prepared for storage, distribution and consumptionafter a period of time beyond the normal life of the food (e.g., five,seven, or more days later). In some embodiments, the fat replacementingredient comprises a partially digestible or non-digestible fat. Incertain cases, the food products have less than or equal to about 30% oftheir calories comprised of fat.

A method of dietary management of a diet-responsive disease or conditionis also provided. Such diet-responsive diseases or conditions canpotentially include, but are not limited to: atherosclerotic disease,cardiovascular disease, coronary heart disease, diabetes, dyslipidemia,hypercholesterolemia, hypertension, metabolic syndrome, obesity,osteoarthritis, overweight, pre-diabetes, satiety, and sleep apnea.Managing life-style and diet may also lower one or more potential riskfactors for certain types of cancer, such as breast, endometrium, colon,kidney, and esophageal cancers.

One non-limiting embodiment of the method of dietary management of adiet-responsive disease or condition comprises:

-   -   (a) providing at least one food item for dietary management of a        diet-responsive disease or condition that is at least        consumer-equivalent relative to a comparable diet food item,        said food item being in a form selected from the group        consisting of a frozen or shelf stable: complete meal, main        course of a meal, appetizer, entree, side dish for a meal,        sauce, dressing, dessert, snack, cooked food, hot food,        microwavable food, cooking oil, and spread;    -   (b) informing at least one medical professional (or        “prescriptor”) of the availability of said at least one food        item if said medical professional is not aware of the same, and        of the medical professional's (or prescriptor's) ability to        supervise a consumer's (or patient's) use of said food item,        and/or, if applicable, to write an order for said at least one        food item;    -   (c) providing a consumer with a plan for reducing their daily        caloric intake by an average amount greater than or equal to        about 25, alternatively, greater than or equal to about 50,        alternatively greater than or equal to about 100 calories per        day when said consumer consumes at least one said food item per        day; and    -   (d) allowing a consumer to purchase said at least one food item        after said consumer is under medical supervision for use of said        food item, and/or said medical professional writes an order, if        applicable, for said at least one food item, wherein said        consumer ingests a quantity of said food items over a period of        time to change (that is, transform or be transformed) from        having a first state of a diet-responsive disease or condition        to a second state wherein said diet-responsive disease or        condition is improved in said second state relative to said        first state.

In another embodiment, a method of controlling caloric intake and/oramount of calories burned by a consumer (or participant) is disclosed.In one version of this embodiment, the method comprises: (a) providing aconsumer with a program or plan for: (i) reducing their average dailycaloric intake over a period of time by greater than or equal to about25 calories, alternatively, greater than or equal to about 50,alternatively greater than or equal to about 100 calories; and (ii)increasing the participant's physical activity to use an additional 50or more, or alternatively 100 or more calories per day; (b) providing aplurality of prepackaged food items to the consumer, each of the fooditems comprising an at least consumer-equivalent, reduced fat foodproduct comprising a fat replacement ingredient, wherein said foodproduct is packaged for storage and distribution, and is suitable forconsumption five or more days after being packaged; and (c) the consumeringests a sufficient quantity of said food products over a period oftime to change (transform or be transformed) from having a first stateof a diet-responsive disease or condition to a second state wherein saiddiet-responsive disease or condition in said second state is improvedrelative to said first state. In certain embodiments, the duration ofthe period of time over which the program is provided may be any numberof months greater than one month, up to a year, or more. In certainembodiments, the method may provide diet and activity guidance in theform of one or more tips (that is, items of information or suggestions)to the participant.

In another embodiment, a system for providing food products isdisclosed. One version of the system comprises: (a) informing at leastone medical professional (or “prescriptor”) of the availability of atleast one food product for dietary management of a diet-responsivedisease or condition if said medical professional is not aware of thesame, and of the medical professional's or prescriptor's ability tosupervise a consumer's (or patient's) use of said food product, and/or,if applicable, to write an order for said at least one food product; (b)providing consumers with controlled access to a supply of food products,wherein the amount of at least one ingredient in the food product istracked by a computer so a consumer can gain access to a food productthat would not otherwise be available; and (c) providing the foodproducts to the consumers. The food products can be supplied in anysuitable manner. Suitable manners of providing a supply of food productsinclude, but are not limited to providing the food products at retailoutlets, such as stores that have pharmacies, and drug stores, orthrough an internet website. In one embodiment, a website is provided atwhich food products may be ordered by consumers, and (1) the website hascontrols so that only those consumers under medical supervision and/orwith orders from a medical professional can order food products from thewebsite and/or (2) the website has controls to control the amount of oneor more ingredients that are provided to and/or consumed by a consumerover a period of time. In other embodiments, the website may comprise aninvention in its own right. The food products may optionally bedelivered to one or more consumers.

In other embodiments, the methods described herein may comprise fewersteps than those described above. Alternatively, the methods cancomprise additional steps.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description will be more fully understood in viewof the drawings in which:

FIG. 1 is a flow chart which shows one embodiment of system forproviding food products.

FIG. 2 is a graph which shows body fat loss over time for several dietprograms.

The embodiment of the system shown in the drawings is illustrative innature and is not intended to be limiting of the invention defined bythe claims. Moreover, the features of the invention will be more fullyapparent and understood in view of the detailed description.

DETAILED DESCRIPTION I. Introduction

The present invention is directed to food products for the dietarymanagement of a diet-responsive disease or condition, methods of dietarymanagement of a diet-responsive disease or condition, and systems forproviding such food products.

Definitions

The term “consumer-equivalent”, as used herein, refers to foods that arejudged by consumers to be equivalent to comparable diet food itemsaccording to the Test Method described herein.

The term “consumer preferred”, as used herein, refers to foods that arepreferred by consumers over comparable diet food items according to theTest Method described herein.

The term “controlling”, as used herein, refers to the treatment,prevention, amelioration, control, delay of progression or dietarymanagement of the diseases, symptoms, conditions and disorders describedherein.

The term “cooked food”, as used herein, refers to food which isprepared, after opening any package containing the same, by exposing thefood to some heat energy, such as: preparing on a stove top, heating ina microwave oven, or by baking in an oven. The term “cooked food”, asused herein, is distinguishable from cereals and snack bars that wereonly cooked prior to packaging and are not intended to be heated afterthe package is opened. It is also within the scope of the term “cookedfood” for such cooked food to have also been partially or fully cookedand/or cured prior to packaging.

The term “entrée”, as used herein, refers to the principal or main dishof a meal.

The terms “food products or food items for the dietary management of adiet-responsive disease or condition”, as used herein, refer to foodproducts with one or more of the fat replacement ingredients describedherein that comprise: (a) foods for special dietary uses; (b) medicalfoods; and, (c) foods that are used to manage one or more of thefollowing diet-responsive diseases or conditions: atheroscleroticdisease, cardiovascular disease, coronary heart disease, type 2 diabetesand/or impaired glucose tolerance, dyslipidemia, hypercholesterolemia,hypertension, metabolic syndrome, obesity, osteoarthritis, overweight,pre-diabetes, satiety, and sleep apnea, or to reduce risk factors forone or more of: breast, endometrium, colon, kidney, and esophagealcancers. In some embodiments described herein, certain diseases orconditions may be specifically excluded from the foregoing list.

The term “foods for special dietary uses”, as used herein, refers tofoods that meet the following definition of “special dietary uses” whichis contained in Title 21, Section 105.3(a)(1) of the United States Codeof Federal Regulations (CFR):

-   -   The term special dietary uses, as applied to food for man, means        particular (as distinguished from general) uses of food, as        follows:        -   (i) Uses for supplying particular dietary needs which exist            by reason of a physical, physiological, pathological or            other condition, including but not limited to the conditions            of diseases, convalescence, pregnancy, lactation, allergic            hypersensitivity to food, underweight, and overweight;        -   (ii) Uses for supplying particular dietary needs which exist            by reason of age, including but not limited to the ages of            infancy and childhood;        -   (iii) Uses for supplementing or fortifying the ordinary or            usual diet with any vitamin, mineral, or other dietary            property. Any such particular use of a food is a special            dietary use, regardless of whether such food also purports            to be or is represented for general use.

The term “full calorie food”, as used herein, refers to a non-reducedcalorie, or non-diet food.

The term “hot food”, as used herein, refers to foods that the consumeris instructed to heat before serving. The food will, thus, have atemperature above room temperature before serving.

The term “hypocaloric”, as used herein, refers to a food item thatprovides a reduction in calories in the range of 20-300 calories incomparison to the same food item which has been prepared withtraditional fat ingredients.

The term “meal replacement products”, as used herein, refers to productssuch as drinks (e.g., drink mixes, packaged drinks, shakes, etc.) andedible bars that are intended to be consumed in the place of a meal.

A “medical food” in the United States is defined by the U.S. Food andDrug Administration (FDA) as a “food which is formulated to be consumedor administered enterally under the supervision of a physician and whichis intended for the specific dietary management of a disease orcondition for which distinctive nutritional requirements, based onrecognized scientific principles, are established by medicalevaluation.” The terms “medical food” and “medical food item” may beused interchangeably herein.

The terms “microwavable” or “microwavable food”, as used herein, referto foods that the consumer is instructed to heat in a microwave ovenbefore serving.

The terms “partially digestible fats” and “non-digestible fats”, as usedherein, refer to fats yielding less than or equal to about 7 caloriesper gram of dietary energy (versus the approximate 9 calories per gramof dietary energy yielded from a traditional digested fat).

The term “prescriptor”, as used herein, refers to a medical professionalor other individual who is authorized to write an order for medicalfoods or foods for special dietary uses, to the extent such an order isnecessary.

The term “salted snacks”, as used herein, refers to foods such as potatochips, corn chips, tortilla chips, curls, puffs, potato sticks, Frenchfries, and shoestring potatoes.

The term “shelf stable”, as used herein, refers to food products thatcan be distributed and sold without the need for refrigeration or frozenstorage to prevent microbial spoilage.

The term “similar to traditional recipe”, as used herein, refers tofoods that are found by consumers to have a taste that comparesfavorably to comparable traditional recipe food items according to theTest Method described herein.

The term “traditional recipe”, as used herein, refers to food that hasnot been altered to reduce the fat, calorie, sugar or other content ofthe food item.

II. The Food Products

Food products for the dietary management of a diet-responsive disease orcondition, as defined above, are provided herein. In some embodiments,the food products may fall into one or more, but not all, of thecategories defined above of: (a) foods for special dietary uses; (b)medical foods; and (c) foods used to manage one or more of theenumerated diet-responsive diseases or conditions. The term “foodproducts” described herein may be referred to alternatively herein as“food items”. The food products may be prepared using recipes which havebeen modified or transformed to replace at least some of the digestiblefat with a fat replacement ingredient and then prepared for storage,distribution and consumption after a period of time beyond the normalshelf life of the food (e.g., five, seven, or more days later), usingone of many preservation techniques.

The food products of interest herein comprise a fat replacementingredient such as reduced calorie fat ingredients or compositions. Thefood products may have less than or equal to about 30% of their caloriesderived from fat. In some embodiments, the fat replacement ingredientcomprises a partially digestible or non-digestible fat-like materialalone, or in combination with other ingredients including, but notlimited to certain reduced calorie triglycerides. For clarity, the 30%figure stated above does not include the fat replacement ingredient(s)described herein. Suitable partially digestible or non-digestiblefat-like materials include, but are not limited to polyol fatty acidpolyesters having at least 4 fatty acid ester groups, wherein saidpolyol is selected from the group consisting of sugars and sugaralcohols containing from 4 to 8 hydroxyl groups and wherein each fattyacid group has 2-24 carbon atoms. Sucrose polyesters (or “SPE's) arespecific types of polyol fatty acid polyesters. These polyol fatty acidpolyesters and SPE's are fat-like materials which are not absorbed bythe body. They have taste and working characteristics similar todigestible fats and oils and may be substituted for them in many foods.

One form of a suitable SPE is OLESTRA™. OLESTRA™ is an SPE with amixture of octa-, hepta-, and hexa-esters of sucrose with fatty acidsderived from edible fats and oils or fatty acid sources that aregenerally recognized as safe or approved for use in certain foods. Thechain lengths of the fatty acids are no less than 12 carbon atoms.OLESTRA™ has zero digestible calories. OLEAN® is the Procter & GambleCompany's (Cincinnati, Ohio, U.S.A.) marketed name for OLESTRA™. Incertain embodiments, it may be desirable for the fat replacementingredients to have between zero and any number less than 9 calories pergram of dietary energy. Reduced calorie fat compositions,partially-digestible and non-digestible fat-like materials, lipids,polyol fatty acid polyesters, SPE's, and OLESTRA™ are further describedin: U.S. Pat. No. 3,600,186, Mattson, et al.; U.S. Pat. No. 4,005,195,Jandacek; U.S. Pat. No. 4,005,196, Jandacek, et al.; U.S. Pat. No.4,919,964, Adams, et al.; U.S. Pat. No. 4,950,140, Pflaumer, et al.;U.S. Pat. No. 4,960,600, Kester, et al.; U.S. Pat. No. 5,021,256,Guffey, et al.; U.S. Pat. No. 5,085,884, Young, et al.; U.S. Pat. No.5,095,008, Pflaumer, et al.; U.S. Pat. No. 5,158,796, Bernhardt, et al.;U.S. Pat. No. 5,194,281, Johnston, et al.; U.S. Pat. No. 5,306,514,Letton, et al.; U.S. Pat. No. 5,306,515, Letton, et al.; U.S. Pat. No.5,306,516, Letton, et al.; U.S. Pat. No. 5,314,707, Kester, et al.; U.S.Pat. No. 5,318,790, Houston, et al.; U.S. Pat. No. 5,419,925, Seiden, etal.; U.S. Pat. No. 5,422,131, Elsen, et al.; U.S. Pat. No. 5,534,284,Corrigan, et al.; U.S. Pat. No. 6,077,556, Letton, et al.; U.S. Pat. No.6,261,628 B1, Howie; U.S. Pat. No. 6,821,545 B2, Bernhardt, et al.; U.S.Pat. No. 7,304,153 B1, Appleby, et al.; and U.S. Pat. No. 7,241,468,Naber, et al.

The fat replacement ingredient may be provided in any suitable form. Foruse in preparing the food products described herein, if an SPE is used,the SPE can be provided in any suitable form, including as is, or in theform of a blend. There are at least two types of blends of OLESTRA™ thatare of interest herein. These include: 1) a blend of OLESTRA™ and anIntermediate Melting Fraction (or “IMF” triglyceride), which is asucrose polyester (SPE) that has been hydrogenated, and 2) a blend ofOLESTRA™ with triglycerides (such as a blend of soybean oil, OLESTRA™,and cottonseed oil). Intermediate Melting Fraction triglycerides arefurther described in U.S. Pat. No. 5,306,516, Letton, et al. The blendsof OLESTRA™ and IMF may be referred to in any suitable manner, such asby designations such as “Blend 40”, “Blend 75”, or “Blend 100” with thenumber denoting the percentage of OLESTRA™ in the blend with the balancebeing the percentage of IMF. The blends of OLESTRA™ and triglyceridesmay also be referred to in any suitable manner, such as by designationssuch as a 75/25 blend, which would comprise 75% OLESTRA™ and 25%triglyceride. All percentages given throughout this specification are byweight, unless otherwise indicated. A number of the aforementionedblends are commercially available from The Procter & Gamble Company ofCincinnati, Ohio, U.S.A. The composition of several blends of interestis summarized in Table 1 below.

TABLE 1 OLESTRA ® Blends Blend % Tri- Name of Blend Number OLESTRA ™ IMFglycerides OLEAN ® Blend 40 40% 60% — DAIRY LEAN ™ H OLEAN ® Blend 7575% 25% — DAIRYLEAN ™ P OLEAN ® Blend 100 100%  — — SOYBEAN ™ OLEAN ®Blend 75/25 75% — 25% BAKELEAN ™ 75

In other embodiments, the fat replacement ingredient may comprise mediumchain triglycerides (“MCT's”) (6-10 carbon length). These are nottypically stored in body fat as they can be directly passed through thelumen of the intestine into the portal vein. This results in MCT's beingmore readily available for conversion to energy for use by the body andnot accumulated in the fat storage compartments of the body. MCT's alsorequire about 10% fewer calories to digest than long chain triglyceridesLCT due to their smaller molecular weight and shorter carbon chains.Common natural sources of MCT are coconut and palm kernel oil.

The relative proportion of the fat replacement ingredient in the foodproducts will, of course, vary considerably depending on the particulartype of food product concerned. The food products may, for example,contain between about 0.1% to about 33% by weight, e.g. from about 0.5%to about 30% by weight, e.g. from about 0.5% to about 20% by weight ofthe fat replacement ingredient, based on the total weight of the foodproduct. The fat replacement ingredient can be substituted for at leastsome of the fats or oils that would be needed in a particular recipe orformula, and conventional ingredients can be used for the balance of therecipe. All indicated proportions and relative weight ranges describedherein are accordingly to be understood as being indicative of preferredand not limiting the invention.

In addition to replacing fat with a fat replacement ingredient, the foodproducts may have reduced carbohydrates provided by carbohydratereplacement ingredients. The food products may also comprise artificialsweeteners, or other sugar substitutes. Such products may be of interestfor diabetic or pre-diabetic consumers.

Conventional additives may be included in the food products, includingany of those selected from: preservatives, chelating agents, osmoticagents, buffers or agents for pH adjustment, effervescing agents, salts,sweeteners, e.g. artificial sweeteners, flavoring agents, coloringagents, taste masking agents, acidulants, emulsifiers, stabilizers,thickening agents, suspending agents, dispersing or wetting agents,antioxidants, texturizers, antifoam agents, and the like.

The food products may be in any suitable form, e.g. in form of acomplete meal, or part of a meal, including, but not limited to, in theform of, or as a component of a frozen or shelf stable: complete meal,main course of a meal, appetizer, entree, a side dish for a meal, sauce,dressing, dessert, snack, and may include cooked foods, hot foods,microwavable foods, cooking oils, and spreads. In some embodiments,certain types of foods may be excluded from the types of foods ofinterest herein. For instance, in some embodiments, the food products ofinterest may exclude one or more of the following: meal replacementproducts, salted snacks, salad dressings, including oils, and certainother food items including one or more food items described in thepatents incorporated by reference herein. In certain embodiments, it maybe desirable for the food products to be either frozen, shelf stable, orto be of a type that would not typically require refrigeration.

There are a number of processes that can be used for food preservationto transform the food products into a shelf stable form. These include,but are not limited to: heating to kill or denature organisms (e.g.boiling, pasteurization); sterilization; oxidation; smoking; vacuumsealing and modification of packaging atmosphere; canning, pHmodification (e.g. acidification, lactic fermentation); dehydration(drying); osmotic inhibition (e.g. use of syrups); low temperatureinactivation (e.g. freezing, refrigeration); ultra high water pressure;pulsed electric field; and irradiation. These processes can be used bythemselves or in any suitable combination (e.g., freeze drying) tomanage microbial growth to effect food preservation. These processes canalso be used with a variety of storage processes which include, but arenot limited to canning, retort packaging, freezing; and packing toprevent contamination.

The food products may be nutritionally complete. That is, they mayinclude naturally present or added, antioxidants, carotenoids, vitamins,minerals, trace elements as well as nitrogen, carbohydrate and fattyacid sources; or, the consumer may obtain additional dietaryfortification from other sources, such as vitamins and/or minerals,which may, for example, be obtained in the form of a multivitamin.

If embodiments of the food products described herein are optionallyfortified with vitamins, the vitamins may comprise fat-soluble vitamins,including vitamin A, vitamin D, vitamin E, and vitamin K. The amount offat-soluble vitamins employed herein to fortify the food products canvary. If desired, the food products can be fortified with a recommendeddaily allowance (RDA), or increment or multiple of an RDA, of any of thefat-soluble vitamins or combinations thereof. Vitamins that arenonsoluble in fat can similarly be included in the food products. Theseinclude, but are not limited to vitamin B complex vitamins, vitamin C,and other micronutrients. The minerals include the wide variety ofminerals known to be useful in the diet, such as calcium, magnesium, andzinc. Any combination of vitamins and minerals can be used in the foodproducts.

In certain embodiments, it may be desirable for the food products tocomply with the American Heart Association nutritional guidelines. Theseinclude: 3 g fat or less, 1 g saturated fat or less, 20 mg cholesterolor less, 480 mg sodium or less, 10% or more of nutrients A, C, iron,calcium, protein, or fiber.

III. Methods for Weight Management, and Treatment of OtherDiet-Responsive Diseases and Conditions

Methods of dietary management of diet-responsive diseases and conditionsare also provided herein. These diseases and conditions may include, butare not limited to: atherosclerotic disease, cardiovascular disease,coronary heart disease, type 2 diabetes and/or impaired glucosetolerance, dyslipidemia, hypercholesterolemia, hypertension, metabolicsyndrome, obesity, osteoarthritis, overweight, pre-diabetes, satiety,and sleep apnea. Managing life-style and diet may also lower one or morepotential risk factors for certain types of cancer, such as breast,endometrium, colon, kidney, and esophageal cancers.

The method of dietary management is applicable to normal weight,overweight, and obese subjects. The term “overweight subjects” as usedherein refers to subjects with a Body Mass Index (BMI) of 25 to 29.9kg/m², implying an excess amount of body weight that includes muscle,bone, fat, and water, in particular an excess amount of fat. The term“obese subjects” as used herein refers to subjects with a BMI of 30kg/m² or higher and an excess amount of body fat, or a BMI of 27 kg/m²with comorbidities. The term “comorbidities”, as used herein, refers tothe presence of one or more disorders (or diseases) in addition to aprimary disease or disorder; or the effect of such additional disordersor diseases. It is generally agreed that men with more than 25% body fatand women with more than 30% body fat are obese.

In one embodiment, the method may comprise a step of providing one ormore at least consumer-equivalent food item in a form selected from thegroup consisting of a frozen or shelf stable: complete meal, main courseof a meal, appetizer, entree, a side dish for a meal, sauce, dressing,dessert, snack, cooked foods, hot foods, microwavable foods, cookingoils, and spreads. The food items may be full flavored. The method maycomprise a step of informing at least one medical professional (orprescriptor) of the availability of at least one food item if themedical professional (or prescriptor) is not aware of the same. Themedical professional or prescriptor can also be informed of theirability to supervise a consumer's (or patient's) use of the food item,and/or, if applicable, to provide approval (e.g., write an order) for atleast one food item. Alternatively, or additionally, the step maycomprise informing consumers of at least one medical professional who,if necessary, can write an order for the food item. The method may alsoinclude a step of providing a consumer with plan for reducing theirdaily caloric intake by an average amount greater than or equal to about25 calories, alternatively, greater than or equal to about 50,alternatively greater than or equal to about 100 calories per day whenthe consumer consumes at least one food item. The method may furtherinclude a step of allowing a consumer to purchase at least one food itemafter the consumer is under medical supervision for use of the fooditem, and/or a medical professional writes an order, if applicable, forthe food item. When carrying out the method, the consumer ingests asufficient quantity of food items over a period of time to change (thatis, transform or be transformed) from having a first state of adiet-responsive condition to a second state wherein the diet-responsivecondition is improved in the second state relative to the first state.In certain versions of this method, the method may comprise a step ofrequiring a consumer to contact a medical professional prior to allowinga consumer to purchase the at least one food item. The food products maybe consumed any suitable number of times over any suitable intervalincluding, but not limited to once daily to e.g. five or more timesdaily.

In another embodiment, a method of controlling caloric intake and/oramount of calories burned is disclosed. In one version of thisembodiment, the method comprises: (a) providing a consumer (orparticipant) with a program or plan for: (i) reducing their averagedaily caloric intake over a period of time by greater than or equal toabout 25 calories, alternatively, greater than or equal to about 50,alternatively greater than or equal to about 100 calories; and (ii)increasing their physical activity to use an additional 50 or more, oralternatively 100 or more calories per day; (b) providing the consumerwith a plurality of prepackaged food items (individually packaged, orcontaining more than one food item per package), each of the food itemscomprising an at least consumer-equivalent, reduced fat food productcomprising a fat replacement ingredient, wherein the food is packagedfor storage and distribution, and is suitable for consumption five ormore days after being packaged; and the consumer ingests a sufficientquantity of the food items over a period of time to change from having afirst state of a diet-responsive condition to a second state wherein thediet-responsive condition is improved in the second state relative tothe first state.

In certain embodiments, the method may provide diet and/or activityguidance in the form of one or more tips (that is, items of informationor suggestions) to the participant. Such tips include, but are notlimited to: (1) when shopping, park further away from the storeentrance; (2) when taking a bus, get off the bus early and walk to thelast stop or two; (3) when cooking, use pureed fruit or applesauce assyrup; (4) add fresh fruit to plain low-fat yogurt instead of havingfruit-flavored yogurt; and (5) take a walk after dinner instead ofwatching television. In certain embodiments, the period of time for thechange in the diet-responsive condition may be any number of monthsgreater than one month (e.g., six months, nine months, etc.), up or upto a year, or more. The diet-responsive condition can be the person'sweight, or any of the other diet-responsive conditions described herein.

Without wishing to be bound by any particular theory, it is believedthat weight loss and weight loss maintenance programs will be moresuccessful (i.e., participants will lose weight and keep it off) if theprogram facilitates long-term compliance to a hypocaloric diet (throughpharmaceutical means, or through more satisfying low-calorie foods)and/or incorporating activity to burn additional calories when theparticipant can no longer completely comply with a low-calorie diet.Such programs are also believed to be more successful if they provide aplan that provides a meal experience where the stomach satiation, andactual eating experience is more like a full calorie meal/plan. As usedherein, a “relatively moderate reduction in daily caloric intake” refersto an average reduction of daily caloric intake of between about 25 and1,000 calories per day, alternatively between about 50 and 500 caloriesper day, alternatively greater than or equal to about 100 calories perday. However, it should be understood that the individual foodsdescribed herein may provide a reduction in calories of between about 1and 1,000, or more, calories in comparison to their full calorieequivalent. It is believed that if a person is able to reduce theirdaily caloric intake by an average of about 100 calories per day, oralternatively to increase their physical activity to use an additional100 calories per day, they may be able to lose about 10 lbs. (4.5 Kg.)per year.

It is also believed that weight loss and weight loss maintenanceprograms will be more successful if they are combined with aphysician-supervised program. The weight loss and weight lossmaintenance program may also comprise a bundle of offerings comprisingrecommended foods, and personalized wellness services including one ormore of the following: nutritional counseling, incorporating additionalphysical activity into a participant's lifestyle, physical fitnesstraining, and behavior modification coaching (including positivevisualizations) that integrates into a participant's life to provide forsustained weight loss and improved health. The program may provide forregular interaction with one or more advisors during the program. Thismay include regular (e.g., weekly, bi-weekly, monthly, quarterly, orsemi-annual) visits to the participant's medical professional, or othercounselor. With respect to physical activity, the participant can, forexample, be instructed to engage in exercise for 30 minutes per daythree to five days a week. The exercise would ideally be continuous forat least 30 minutes, but can also be in separate periods of exerciseactivity that total 30 minutes per day.

IV. System for Providing the Food Products

A system, method, or program for providing the food products is alsoincluded herein. The system may comprise a step (a) of informing atleast one medical professional (or prescriptor) of the availability ofat least one food product for the dietary management of adiet-responsive disease or condition, particularly if the medicalprofessional is not aware of the same. This step may also includeinforming the medical professional of the medical professional's (orprescriptor's) ability to supervise a consumer's (or patient's) use ofthe food product, and/or, if applicable, to write an order for the foodproduct. Alternatively, or additionally, the system may comprise a stepof providing the name of at least one medical professional or practice(or prescriptor's office or practice) for consultation by participants(patients or consumers) and, if applicable, for writing orders for foodproducts for participants. The system may comprise a step (b) ofproviding participants with controlled access to a supply of foodproducts, wherein the amount of at least one ingredient in the foodproduct is tracked by a computer so a participant can gain access tofood products that would not otherwise be available; and a step (c) ofproviding the food products to the participant.

The medical professional can be informed of the system or program in anysuitable manner. The medical professional can be informed of the systemor program directly by the manufacturer, or indirectly such as byproviding website access, or through a medical colleague. It should beunderstood that whenever the terms “website”, “internet”, “e-mail”, and“database” are used herein, these sites or items may be accessed using acomputer such as a general purpose digital computer, wireless handhelddevices, or other devices. Additional ways of directly informing themedical professional of the system or program include mailings ofliterature and/or samples or offer of samples, in-person detailingvisits to the medical professional, prescriptor or their employees,journal ads or articles, television, ads, symposia/conventioninformation booths, speeches, sponsorships, etc.

The at least one medical professional may comprise a network of medicalprofessionals or prescriptors. The network of medical professionals orprescriptors can comprise any suitable number of medical professionalsgreater than or equal to one. The medical professionals in the networkcan comprise any suitable type or types of medical professionalsincluding, but not limited to: physicians, including primary carephysicians and specialists, nurse practitioners, and pharmacists. Themedical professionals may include those who have an existing medicalpractice, a group of medical professionals assembled for the purpose ofcarrying out the system described herein, or combinations thereof. Ifthe U.S. FDA or other regulatory guidelines change so that individualswith other backgrounds (such as those delegated or authorized by medicalprofessionals) are permitted to supervise the use of the food productsdescribed herein, and, if required, to write an order for the same, thensuch individuals will also be included within the scope of the term“medical professional”, as used herein.

Eligibility requirements may be established for participants to be afood product recipient. These eligibility requirements may be linked toa particular diet responsive condition. In one non-limiting embodiment,the eligibility requirement may be that the participant is overweight.Each medical professional may identify one or more patients that meetthe eligibility requirements to be a food product recipient. The medicalprofessional may also either serve to supervise the participantthroughout the participant's enrollment in the program, or refer theparticipant to another medical professional who can serve to supervisethe participant during the program.

A participant may learn about the program in any suitable manner,including during a routine office visit or through marketing materials(such as through a brochure mailed to their home, media advertising suchas print, television, internet, mobile network, radio) which may bedirected to the prospective participants, or provided under thesponsorship of the physician, by word of mouth, or other means.

It may be desirable for the prospective participant to have an initialconsultation with a medical professional, and/or with others (such asrepresentatives designated by the program sponsor). The initialconsultation may take place in person, such as an office consultation,or via other communication means which can be live (e.g., a phone call),or serial via a digitally stored and transmitted conversation (e.g.,email, workspace, instant message). During the consultation, aprospective participant will be informed about the program and providedwith information about the program (which may include a brochure or awebsite or phone bank referral).

The participant may optionally be provided with a participant code orunique identifier (e.g., identification number, password, or the like)during the initial consultation, or the participant code may be providedby a customer service provider. The participant code may be logged intoa database by the medical professional's practice, or by others, andused to identify and validate the participant during the remainingportions of enrollment or the program, such as for the food orderingprocess. The unique identifier (or identifier) can be the participant'stelephone number, chart number, or other unique personal identifier, ora unique code assigned for this purpose.

The food products can be made by any suitable manufacturer and brandedin any suitable manner. The food products can, for instance, be made bythe same company that will sell the food products, or they can be madeby one or more contract manufacturers on behalf of the company that willbrand and sell the food products. The food products can be marketedunder a trusted and/or trademarked/service marked name which may be amedicinal brand, a diet food brand, a full fat food brand, or the brandof a consumer-known company. Any such contract manufacturers may, ifdesired, also distribute the food, for instance under the brand of thebrand owner or service owner. In addition, a holistic business platformcan be provided which enables multiple companies to provide foodproducts leveraging their brand names. The holistic platform caninclude: order entry/verification; product specifications for foods thatwill meet the applicable food requirements; and, up-to-date tracking andreporting, if necessary, to comply with food regulations, etc.

The food products can be supplied in any suitable manner. Suitablemanners of providing a supply of food products include, but are notlimited to providing the food products at retail outlets, such as storesthat have pharmacies, in-store medical clinics, and drug stores; or,through a website.

Any or all of the food products may be selected by the participant,although in some embodiments, one or more food items may be pre-selectedfor the participants. In one embodiment, a website is provided at whichfood products may be ordered by participants, and the website may havecontrols so that only those participants under the supervision of amedical professional, and/or with orders from a medical professional canorder food products from the website. The website may also be linked toa database that may track the amount of food products ordered by eachparticipant. The website may have controls to control the amount of oneor more ingredients are consumed by a participant over a period of time.In other embodiments, the website may comprise an invention in its ownright. The website may be provided with menu planning, grocery lists,and recipes, among other things, to assist the participants. Thedatabase may also include or be linked to shopper loyalty databasesand/or credit card databases. The food products may optionally bedelivered to one or more participants for consumption in place of theirusual foods.

The website may or may not be password protected. In one embodiment, thewebsite is not password protected so that anyone may visit the site andsee the food offerings. However, to begin ordering food, the program mayrequire that a participant enter their unique ID number which may beverified or rejected based on matching information entered by theparticipant. The ID number validates that the participant has beenqualified by their physician, meets the admission criteria, and enablesplacement of food orders.

It may be desirable to provide controlled access to the supply of foodproducts. The amount of food a participant may order in a given periodof time may be based on the daily intake limits established for theparticular food products. For example, the website may limit thepurchase of food (OLESTRA™) to a daily average of 10 grams per day on arolling basis. The consumer may, for example, start with 300 grams ofOLESTRA™ in their account, and for each day that passes after the orderdate, the consumer may accrue ten grams to replace the ten they areassumed to have eaten. The accrued amount plus the balance available inthe consumer's account can be set so that it never exceeds a certainamount (e.g., 300 grams). This will ensure compliance with a 10.4grams/day mean intake limit established (300 g/30 d=10 g/day) whileproviding consumers the flexibility to have an ample supply of food onhand. In addition to this purchase control system, consumers may beinstructed to enjoy, or otherwise consume, a certain number (e.g., 1, 2,3, etc.) of food items per day as guidance to help them manage theirconsumption of the order period.

Participants may use the website to order all or part of their foodproducts for home delivery. Foods that are frozen may be shipped usingdry ice or refrigerated transportation. Refrigerated transportation maybe at any of the following temperatures: above (e.g., slightly above),at, or below freezing temperatures.

The program described above allows medical professionals to supervisethe patients (or participants) and, if necessary, to write an order forthe food products for eligible participants. The participant may theninitiate the order via the website setting in motion the validationprocess and fulfillment and delivery of the food product to their home,which may occur, for example, in about 2-3 days. Additionally, theprogram may provide a participant with the ability to obtainsupplemental support from one or more support providers to assist themon their weight management (or other condition management) journey. Theone or more support providers can comprise a professional services team,or separate support providers. The support providers may include, butare not limited to: a medical professional, a registered dietician, apersonal trainer, and a life coach. Such supplemental support can bedelivered live during an in-person visit, such as at an office or theparticipant's home, or via the internet, instant message, phone, digitalor digital serial communication.

The participant can purchase the food products in any suitable manner,such as with a credit card or a debit card over the telephone, internet,etc.; with an order or debit against a prepaid account, by payingdirectly to a retailer, manufacturer, or medical professional, etc.

The program described herein may also have a feature of providing theparticipant with a log or journal. The log or journal may include atable for the participant to record any suitable information including,but not limited to: the items consumed on a daily basis, the amount ofeach item consumed (e.g., number of servings), the number of calories ineach item, and the amount of fat (e.g., grams of fat) in each item, andtotals for the same. The log or journal may contain any other suitableinformation including, but not limited to: a space for recording themethod by which they reduced their daily caloric intake and/or increasedthe number of calories they burned; tips for reducing the participant'scaloric intake and/or for increasing the number of calories they burn;and motivational and/or positive reinforcement statements. The log orjournal can be in physical form (e.g., paper or electronic paper withappropriate stylus or writing instrument, or it can be in digital form,such as in the form of software where the resulting document or databaseresides on a local PC, or a LAN or web-accessed server).

EXAMPLES

Tables 2-5 contain non-limiting examples of the food products describedherein. Table 6 describes the properties of these food products andTable 7 compares certain of these properties to comparable full caloriefood items.

TABLE 2 GENERAL TSO'S CHICKEN Serving = 274 gm % in Component/IngredientWt. (gm) Formula Sauce 64.00 18.82% Broccoli Florets, IQF (IndividuallyQuick Frozen) 85 Chicken, Breaded/Battered IQF 125.43 34.90% TOTALS274.43 100.00% Sauce: Water 27.51 42.99% Soy Sauce, light 7.46 11.66%Brown Sugar, dark 6.39 9.99% Corn Syrup 5.11 7.99% Sherry Wine, salted3.20 5.00% Chili Garlic Sauce 5.37 8.39% Sugar, granulated 2.56 4.00%Modified Corn Starch 2.30 3.60% Garlic Puree 1.92 3.00% Sesame Oil 0.641.00% Rice Vinegar 0.64 1.00% Ginger Puree 0.48 0.75% Yeast Extract 0.260.40% Xanthan Gum 0.06 0.10% Caramel Color 0.06 0.10% White Pepper,ground 60 0.03 0.05% TOTALS 64.00 100.00% Breaded/Battered Chicken:Chicken Breast Meat, raw 101.45 80.88% Batter 18.45 14.71% Predust 5.534.41% TOTALS 125.43 100.00% Batter: Water 12.30 66.67% Batter/Breader6.15 33.33% TOTALS 18.45 100.00%

Batter Preparation:

1. Combine water and batter. Mix until smooth.

Chicken Preparation:

1. Toss chicken in predust2. Coat chicken with batter.3. Fry chicken in OLEAN® DAIRY LEAN™ at 400° F. for 1 minute.4. Bake chicken at 350° F. convection oven for 8-10 minutes (internaltemperature at 170° F.).

Sauce Preparation:

1. Pre-blend dry ingredients.2. Combine remaining ingredients add pre-blend. Mix well.

3. Bring up to 190° F.

4. Cool and bring to 100% (add water to return sauce to 100% of desiredweight)

Preparation of General Tso's Chicken and Freezing Instructions:

1. Place breaded chicken and broccoli on tray.2. Pour sauce over chicken.3. Seal and freeze.

TABLE 3 CREAMY BALSAMIC VINAIGRETTE SALAD DRESSING Serving = 3 gm % inComponent/Ingredient Wt. (gm) Formula Water 8.41 28.02% Balsamic Vinegar7.69 25.63% OLESTRA ™ - OLEAN ® Soybean ™ 5.71 19.02% Extra Virgin OliveOil 2.70 9.01% Canola Oil 3.00 10.01% Sugar 1.32 4.41% Salt 0.65 2.16%Caramel Color 0.07 0.24% Garlic Powder 0.28 0.92% Xanthan gum & ModifiedGum Acacia 0.12 0.41% Black Pepper, ground 30 0.05 0.16% TOTALS 30.00100.00%

Dressing Preparation:

1. Pre-blend gum with water under high shear.2. Blend in remaining dry ingredients and vinegar.3. Add oil and OLESTRA™ in a thin stream.4. Blend until thoroughly emulsified.

TABLE 4 BUTTER POPCORN Serving = 30 gm Component/Ingredient Wt. (gm) %in Formula Popcorn 24.73 86.39% OLESTRA ™- 2.88 10.08% OLEAN ® SOYBEAN ™Salt, flour 1.79 1.73% Butter Flavor 0.58 1.73% Annatto Color 0.02 0.07%TOTALS 30.00 100.00%

Popcorn and Bag Preparation:

1. Place all wet ingredients (OLEAN® & annatto color) into a 4,000 mlbeaker.2. Place a stir bar into beaker and place beaker on top of a heating &stirring plate3. Turn on heat to ⅓ high and stir until OLEAN® is completely melted(140°-150° F.).4. Turn off heat. Sieve dry ingredients (salt and flavor) into beaker.5. Continue stirring until OLEAN® slurry cools to 100° F.+/−10° F.6. Weigh popcorn kernels into bowl.7. Weigh hot slurry over popcorn kernels. Mix well using spatula.8. Weigh 30 g coated popcorn kernels into popcorn bag, placing in middlethird of bag9. Seal bag using hand sealer.10. Fold bag so the finished bag is in thirds. Place in plastic zipperbag and seal.11. Hold under ambient condition until OLEAN® solidifies.

Consumer Preparation:

1. Remove overwrap. Place bag, unfolded, in center of microwave oven.2. Set microwave on High, and set oven timer for 1¼ to 3 minutes (theactual cooking time will be between pops). Turn microwave oven off. Donot leave microwave oven unattended as overcooking may result inscorching.

TABLE 5 APPLE TURNOVER Serving Size = 125 gm Component/Ingredient Wt.(gm) % in Formula Pie Dough 64.00 51.20% Apples, slices, IQF(Individually Quick 30.00 24.00% Frozen) Apple Pie Sauce 30.00 24.00%Cinnamon Sugar 1.00 0.80% TOTALS 125 100.00% Pastry Dough All PurposeFlour, bleached 35.87 56.04% Water, ice 13.43 20.99% OLESTRA ™ - 11.6818.25% OLEAN ® BAKELEAN ™ 75P Sugar, granulated 1.75 2.74% Salt 0.701.10% Natural Butter Flavor 0.29 0.46% Nonfat Dry Milk 0.27 0.42% TOTALS64.00 100.00% Apple Pie Filling Water 20.21 67.36% Sugar 5.91 19.69%Sucralose Blend 2.18 7.25% Modified Food Starch 1.25 4.15% Lemon Juice,single strength 0.31 1.04% Salt 0.09 0.31% Cinnamon, ground 0.06 0.21%TOTALS 0 100.00% Cinnamon Sugar Sugar 0.99 99.00% Cinnamon, ground 0.011.00% TOTALS 1.00 100.00%

Dough Preparation:

1. Pre-blend flour, sugar, salt and flavor.2. Add dry pre-blend to a food processor. Add OLESTRA™. Pulse untilcrumbly.3. Add ice water evenly over flour/OLESTRA™ mixture.4. Pulse until dough is combined but still crumbly.5. Form into balls, flatten, wrap in plastic and refrigerate for atleast 30 minutes.

Filling Preparation:

1. Pre-blend dry ingredients.2. Combine pre-blend with remaining ingredients.

3. Bring to 190° F. Hold for 1 min. 4. Chill. Sugar/CinnamonPreparation:

Blend ingredients.

Turnover Preparation:

1. Roll dough to ⅛″ thickness using a suitable dough laminator.2. Cut dough into 5½″ round.3. Deposit apple pie filling on bottom crust.4. Crimp crust on top and make slits for vent holes. Sprinkle withcinnamon sugar.5. Bake for 20 minutes at 350° F. (low fan) until golden brown.

Consumer Preparation:

1. Microwave on high for 1¼ to 1½ minutes.2. Let sit 1 minute before serving.Alternatively can be baked in a 350° F. oven for 15-20 minutes or untilhot.

TABLE 6 OLESTRA ™ Based Food Items g % daily value % Calories Total g gOLESTRA ™ Calories from fat Fat Cholesterol Sodium Carbs ProteinOLESTRA ™ (of total wt) ENTREES General Tso's Chicken 260 20 4 20 33 1027 21.5 8.5 SAUCES & DRESSINGS Creamy Balsamic 60 50 6 0 260 3 0 5.7 19Vinaigrette Dressing SNACKS Microwave popcorn 100 10 2 0 25 7 3 2.88 9.6DESSERTS Apple Turnover 200 25 5 0 13 14 4 11.68 9.2

TABLE 7 Comparison of the Food Products With Full Calorie Foods FoodProduct and Comparable Serving Total Full Calorie Food size g caloriesFat g Food Product General Tso's Chicken 274 260 2.5 Full Calorie PFCHANG'S ® General 485 923 37 Food Tso's Chicken Δ −211 −663 −34.5 Δ @equal serving size −261 SAUCES & DRESSINGS Food Product Creamy BalsamicVinaigrette 30 60 6 Dressing Full Calorie KRAFT ® Balsamic 42.5 120 11Food Vinaigrette Dressing Δ −12.5 −60 −5 Δ @ equal serving size −25SNACKS Food Product Microwave popcorn 30 100 1 Full Calorie POP SECRET ®28 100 9 Food Microwave popcorn Δ +2 0 −8 Δ @ equal serving size −7DESSERTS Food Product Apple Turnover 126 200 3 Full Calorie MCDONALD'S ®Apple Pie 77 250 13 Food Δ +49 −50 −10.0 Δ @ equal serving size −209

FIG. 2 is a graph which shows body fat loss over time for several dietprograms. In the study represented by the graph, overweight men areplaced into three groups for a nine month study. The first group is acontrol group that consumes a diet with 33% fat, a typical Americandiet. The second group is placed on a reduced fat diet with 25% fat. Thethird group is placed on a diet with fat substituted with OLESTRA™replacing one-third of dietary fat. The study that led to the resultsshown in FIG. 2 is further described in J. C. Lovejoy, et al.,Consumption of a controlled low-fat diet containing OLESTRA™ for 9months improves health risk factors in conjunction with weight loss inobese men: the Ole' Study, International Journal of Obesity (2003) 27,1242-1249, and G. A. Bray, et al., A 9-mo randomized clinical trialcomparing fat-substituted and fat-reduced diets in healthy obese men:the Ole Study, Am J Clin Nutr 2002; 76:928-34. The diet with fatsubstituted with OLESTRA™ differs from the method described herein inseveral respects, but shows the weight loss and weight loss maintenancepotential of a diet containing OLESTRA™.

As shown in FIG. 2, when overweight men consume OLESTRA™ as part of avaried diet over nine months, weight loss continues for the duration ofthe study, whereas individuals receiving a typical low calorie orhypocaloric diet regained most of the initial weight lost. Withoutwishing to be bound by any particular theory, it is believed thatsubjects on a reduced fat diet will consume a greater amount ofnon-study foods during the study due to their diet being less palatablethan the control diet or the OLESTRA™ diet. The OLESTRA™ diet also has astatistically significant diet effect on cholesterol, LDL andtriglycerides, which decreases in fat-substituted diet (OLESTRA™) butnot in the other groups at 9 months.

Test Methods

It may be desirable for the food items described herein to be ratedequal to in taste and/or satiety, or consumer preferred in taste and/orsatiety relative to comparable diet food items. In other words, the fooditems may be at least consumer-equivalent to comparable diet food items.The food items may, for instance, be equivalent in taste relative tocomparable diet food items, but may have greater satiety due toincreased portion size (substantially the same number of total calories,but greater weight), aesthetics (e.g., appearance or mouth feel) and/orinclusion of other satiating components. It may also be desirable forthe food items to be similar to traditional recipe food items (that is,be found to have a taste that compares favorably to comparabletraditional recipe food items).

The food items used for basis of comparison are commercially availablefoods, which term includes frozen, shelf-stable, and canned foods. Theterm “comparable” when used in reference to diet or traditional recipefood items, refers to evaluation of the test product relative to thesame dish or menu item as both are usually served. Thus, one wouldcompare one General Tso's chicken dish to another, one apple turnover toanother, when both are heated for serving, etc. The taste of the foodproducts can be evaluated by providing the panelists with the foodproducts and having them complete a survey that compares the food itemsto comparable dishes of the diet food items (e.g., STOUFFER'S® LEANCUISINE®), or traditional recipe food items (e.g., non-diet foods, e.g.,STOUFFER'S® regular foods), respectively. In some cases, panelists mayprefer the taste of diet foods (e.g., STOUFFER'S® LEAN CUISINE®) to thefull calorie versions of the same (e.g., STOUFFER'S® regular foods). Insuch cases, if it is desired to determine whether the food products aresimilar to traditional recipe food items, the taste of the food productscan be compared to the comparable diet food item. The taste of the foodscan be evaluated by asking the following question:

What is your overall opinion of this product? The person evaluating theproduct can be offered the following choices for expressing theiroverall opinion about the product: Like it extremely (+4); Like it verymuch (+3); Like it moderately (+2); Like it slightly (+1); Neither likenor dislike it (0); Dislike it slightly (−1); Dislike it moderately(−2); Dislike it very much (−3); and Dislike it extremely (−4).

Some or all of the questions can be presented in a live verbal interviewin person or by telephone, or by survey either: written, computerpresented and inputted (for example, over the internet), or bymobile/personal electronic device interaction.

A food item is at least consumer-equivalent relative to a comparablediet food item if the score of the food item is no more than 0.4 pointslower than the diet food item when tested among at least 30 panelists. Afood item is similar to a comparable traditional recipe food item if themean difference in score between the food item and the traditionalrecipe food item is less than 0.5 points lower than the traditionalrecipe food item when tested among at least 30 panelists. Of course, inthe case of either definition, the score of the food item can be higherthan that of the comparable food item. The food item may even bepreferred to the traditional recipe food item if the mean score for thefood item is 0.5 points or more than the score of the traditional recipefood item when tested among at least 30 panelists.

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue. For example, a dimension disclosed as “40 grams” is intended tomean “about 40 grams”.

It should be understood that every maximum numerical limitation giventhroughout this specification includes every lower numerical limitation,as if such lower numerical limitations were expressly written herein.Every minimum numerical limitation given throughout this specificationwill include every higher numerical limitation, as if such highernumerical limitations were expressly written herein. Every numericalrange given throughout this specification will include every narrowernumerical range that falls within such broader numerical range, as ifsuch narrower numerical ranges were all expressly written herein.

All documents cited in the Detailed Description of the Invention are, inrelevant part, incorporated herein by reference; the citation of anydocument is not to be construed as an admission that it is prior artwith respect to the present invention. To the extent that any meaning ordefinition of a term in this written document conflicts with any meaningor definition of the term in a document incorporated by reference, themeaning or definition assigned to the term in this written documentshall govern.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

1. A food product in a prepackaged form selected from the groupconsisting of a frozen or shelf stable: complete meal, main course of ameal, appetizer, entree, side dish for a meal, sauce, dressing, dessert,snack, cooked food, hot food, microwavable food, cooking oil, andspreads, wherein said food product is prepared using a recipe which hasbeen modified to replace at least some digestible fat in the recipe witha fat replacement ingredient, said food product is in a packaged formfor storage and distribution, and is suitable for consumption five ormore days after being packaged, and said food product comprises a foodproduct for the dietary management of a diet-responsive disease orcondition.
 2. A food product according to claim 1 comprising caloriesand fat, said food product having less than or equal to about 30% ofsaid calories derived from fat.
 3. A food product according to claim 1comprising a partially digestible or non-digestible fat replacementingredient.
 4. A food product according to claim 3 wherein saidpartially digestible or non-digestible fat replacement ingredientcomprises an edible, substantially non-absorbable, substantiallynon-digestible polyol fatty acid polyester having at least 4 fatty acidester groups, wherein said polyol is selected from the group consistingof sugars and sugar alcohols containing from 4 to 8 hydroxy groups andwherein each fatty acid group has from 2 to 24 carbon atoms.
 5. A foodproduct according to claim 3 wherein said partially digestible ornon-digestible fat replacement ingredient comprises a sucrose polyester.6. A food product according to claim 3 wherein said partially digestibleor non-digestible fat replacement ingredient comprises a mixture ofocta-, hepta-, and hexa-esters of sucrose with fatty acids derived fromedible fats and oils or fatty acids, wherein the chain lengths of thefatty acids contain no less than 12 carbon atoms.
 7. A food productaccording to claim 1 which is rated at least consumer-equivalent to acomparable diet food item according to the Test Method.
 8. A foodproduct according to claim 1 comprising less than or equal to 1 gram ofsaturated fat.